Phase 3 Oesophageal Cancer Trial, Recruiting NCT06644781 Sponsor: Daiichi Sankyo Condition: Oesophageal Cancer
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Phase 3 Oesophageal Cancer Trial, Recruiting

NCT06644781
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years old or older
  • You have been diagnosed with esophageal squamous cell cancer (a type of throat/food pipe cancer) that cannot be removed by surgery and has either spread to nearby areas or to other parts of the body, confirmed by a tissue or cell sample
  • Your cancer got worse after receiving one previous treatment that included platinum-based chemotherapy and an immunotherapy drug (no more than one prior treatment course)
  • You are able to provide a tissue sample from your tumor that meets the quality standards required by the trial
  • You have at least one area of cancer that can be measured on a CT or MRI scan (not from a previously treated area, unless that is the only option and clear growth can be shown)
  • Your general health and ability to carry out daily activities is rated as fully active or restricted only in physically strenuous activity (confirmed by a doctor within 7 days before starting treatment)

Who may not be able to join:

  • You have previously received certain specific drugs targeting a protein called B7-H3, including orlotamab, enoblituzumab, or similar treatments
  • You have previously received a type of chemotherapy called a topoisomerase inhibitor
  • Your cancer has been confirmed as a specific subtype called adenosquamous carcinoma
  • You are unable to tolerate any of the chemotherapy options used in the comparison group of this trial due to previous reactions or disease progression
  • Your cancer is growing into nearby critical structures such as the aorta (main blood vessel) or airways, putting you at higher risk of bleeding or abnormal connections forming between organs (confirm with trial site)
  • You have active or symptomatic brain metastases (cancer that has spread to the brain), spinal cord compression, or cancer affecting the lining of the brain or spinal cord that is untreated or needs medication to control symptoms — though stable, treated brain metastases with no symptoms and no steroid use for at least 2 weeks may be acceptable (confirm with trial site)
  • You have had a stroke, mini-stroke, other arterial blood clot event, or a blood clot in the lungs within the past 6 months
  • You have a significant disease affecting the surface of your eyes (corneal disease)
  • You have a history of non-infectious lung inflammation (ILD/pneumonitis) that needed steroid treatment, or you currently have or are suspected to have this condition
  • You have serious lung problems from any cause, including severe asthma, COPD, restricted lung function, fluid around the lungs, a previous lung removal surgery, or a need for supplemental oxygen
  • You are currently taking regular steroid medication at a dose of 10 mg or more of prednisone (or equivalent) per day — low-dose inhaled, topical skin, or joint-injection steroids may be acceptable (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 9089926400

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Daiichi Sankyo
Registry
ClinicalTrials.gov
Start date
27 March 2025
Est. completion
1 June 2028

Where this trial is recruiting

🇧🇪 Belgium 🇨🇳 China 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇵🇱 Poland 🇷🇴 Romania 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇺🇸 United States

Primary endpoints

Overall Survival (OS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov